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CAPLIN STERILES GETS USFDA APPROVAL FOR PROCAINAMIDE HYDROCHLORIDE INJECTION

Chennai, Feb 05, 2025: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Procainamide Hydrochloride Injection USP, 1g/10mL and 1g/2mL Vials, a generic therapeutic equivalent version…

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CAPLIN STERILES GETS USFDA APPROVAL FOR LEVETIRACETAM IN SODIUM CHLORIDE INJECTION, INFUSION BAGS

Chennai, Jan 17, 2025: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Levetiracetam in Sodium Chloride Injection, 500mg/100mL, 1000mg/100mL and 1500mg/100mL infusion bags (Large Volume…

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CAPLIN POINT RECEIVES ESTABLISHMENT INSPECTION REPORT (EIR) FROM FDA WITH ZERO 483 OBSERVATIONS

Chennai, January 06, 2025: Caplin Point Laboratories Ltd. (“Caplin Point” or the “Company”) (BSE: 524742 | NSE: CAPLIPOINT), announced today that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the recent inspection conducted at Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi. The unannounced…

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CAPLIN STERILES GETS USFDA APPROVAL FOR DIFLUPREDNATE OPHTHALMIC EMULSION

Chennai, Dec 16, 2024: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Difluprednate Ophthalmic Emulsion, 0.05% (Eye drops), a generic therapeutic equivalent version of the…

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Completion of inspection by ANVISA-Brazil at the facility of Caplin Steriles Limited

This is to inform you that ANVISA- Brazil conducted an inspection of Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi. The inspection was conducted between August 12th and 16th, 2024 and concluded with zero observations. Chairman Mr.C.C.Paarthipan added “It is indeed gratifying to have two back to back audits with Zero observations. We…

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Caplin Point listed on Forbes Asia’s “200 Best Under a Billion” for 2024

Caplin Point Laboratories Ltd has been recognized yet again in Forbes Asia’s 200 Best Under a Billion list for the year 2024, a compilation that underscores companies’ sustained and robust performance across critical benchmarks. Carefully selected from a substantial pool of more than 20,000 publicly traded companies across the Asia-Pacific region, 200 enterprises with annual…

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Completion of Unannounced US FDA Inspection at the facility of Caplin Steriles Limited

This is to inform you that the United States Food and Drug Administration (US FDA) conducted an unannounced inspection of Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi. The inspection was conducted between August 5th and 9th, 2024 and concluded with zero observations. This outcome underscores the company’s strong commitment to maintaining the…

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CAPLIN STERILES GETS USFDA APPROVAL FOR TIMOLOL MALEATE OPHTHALMIC SOLUTION USP

Chennai, Aug 08, 2024: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Timolol Maleate Ophthalmic Solution USP, 0.5% (Eye drops), a generic therapeutic equivalent version…

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CAPLIN STERILES GETS USFDA APPROVAL FOR EPHEDRINE SULFATE INJECTION USP

Chennai, JULY 19, 2024: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ephedrine Sulfate injection USP, 50 mg/mL Single Dose vial, a generic therapeutic equivalent…

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CAPLIN STERILES GETS USFDA APPROVAL FOR PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP

Chennai, May 24, 2024: Caplin Steriles Limited (Caplin), a Subsidiary of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% (eye drops), a generic therapeutic equivalent…

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